A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhea
Intervention: Calcium Carbonate (Drug); nelfinavir (Drug); lamivudine (Drug); loperamide (Drug); Calcium carbonate not administered (Other); nelfinavir (Drug); lamivudine + zidovudine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The purpose of this study was to determine the efficacy and safety of calcium carbonate for
the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of
calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated
diarrhea.
Clinical Details
Official title: A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Secondary outcome: Time to first occurrence of protocol-defined diarrheaThe outcome of calcium carbonate plus loperamide in treating
subjects who experienced diarrhea Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide Safety evaluations including physical exam, weight and vital signs measurements Safety assessment of laboratory parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Antiretroviral-naive patients with HIV-1 infection
- not more than 2 loose stools per day or any preexisting or emerging medical condition
that would interfere with the evaluation of therapeutic response of the study drug
- No antidiarrheal medication within 7 days prior to entry
Exclusion Criteria:
- Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days
prior to study entry
- Bloody stools within 7 days prior to study entry
- Any unstable or severe intercurrent medical condition, including active opportunistic
infections
Locations and Contacts
Pfizer Investigational Site, BIRMINGHAM, Alabama 35233, United States
Pfizer Investigational Site, Ft. Lauderdale, Florida 33308, United States
Pfizer Investigational Site, NEW YORK, New York 10011, United States
Pfizer Investigational Site, Huntersville, North Carolina 28078, United States
Pfizer Investigational Site, Houston, Texas 77098, United States
Pfizer Investigational Site, Austin, Texas 78705, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2003
Ending date: August 2003
Last updated: April 1, 2008
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